Post-approval drug problems could be due to poor adherence in trials, study finds
MCLEAN, Va. — Unexpected toxicities from prescription drugs that emerge years after regulatory approval may be due to poor medication adherence in clinical trials, according to a new study.
While much attention on medication adherence has focused on patients not taking the already approved drugs prescribed to them or not taking them properly, the new study, released Tuesday by Consumer Health Information, found problems with adherence in clinical trials as well.
"Patient adherence in clinical trials must always be higher than that of the general population," Consumer Health Information president and CEO Dorothy Smith said. "Our challenge is to get patient adherence in clinical trials up to 95% so patients can be assured it is safe to take the FDA-approved dose."
According to the study, which looked at data from over the past 20 years, patient adherence wasn’t monitored between 1997 and 1999 in 53% of clinical trials of drugs that are still on the market today. Meanwhile, up to 30% of study patents did not take the full dosage, and patients could not understand 35% to 94% of informed consent documents. At least half of patients didn’t tell the study team that they had missed doses, and many did not realize that missing doses could endanger the lives of millions of people after a drug’s approval because undetected poor adherence could result in inaccurate dosing.
Smith recommended that clinical trial investigators develop adherence strategies and integrate behavior modification; determine how many doses of each drug can be missed without jeopardizing the therapeutic outcome; include patient adherence results as an outcome of the clinical trial and publish it in the package insert; create informed consent and patient-friendly programs that patients will understand; and gain patient trust so they provide honest feedback about any problems they have.
Unexpected toxicities have resulted in the FDA cutting drug dosages and withdrawing approval for others, but may be occurring because patients in the general population are more adherent than those in the clinical trials.
Tough new regulations for compounding pharmacies could be on the way, attorney says
WASHINGTON — Massachusetts and New Jersey lately have been cracking down on sterile compounding pharmacies alleged to violate safety regulations, but the crackdown may soon go nationwide, predicted a legal firm focused on the matter.
LeClairRyan attorney Michael Ruggio said officials in several states were increasing scrutiny of compounding pharmacies in the wake of an outbreak of fungal meningitis linked to the New England Compounding Center, which so far sickened 696 people and killed 45, according to the Centers for Disease Control and Prevention.
"Our team has already received calls from compounding pharmacies in states such as Colorado, Minnesota and Pennsylvania," Ruggio, leader of LeClairRyan’s compounding pharmacy investigation and litigation team, said. "They are receiving warning letters from their state boards of pharmacy, and in one state, a prosecutor is exploring whether to file criminal charges for alleged safety violations. The takeaway here is clear: The meningitis outbreak amounts to a game-changer for compounding pharmacies everywhere; this sector will never be the same."
Meanwhile, Food and Drug Administration commissioner Margaret Hamburg in November 2012 called for FDA oversight of compounding pharmacies, while earlier that month, Rep. Edward Markey, D-Mass., proposed legislation to strengthen the federal government’s ability to regulate compounding and end the "regulatory black hole."
"Because compounding pharmacies can be lucrative, it is not unusual for conventional pharmacies to attempt to pursue this line of business," Ruggio said. "As a result of the outbreak, however, this is going to become far more difficult to accomplish. States are going to be rolling out new hoops and hurdles related to licensure, and the federal government might well end up subjecting compounding pharmacies to the stringent regulations that now apply to mainstream pharmaceutical companies, radically altering the cost-benefit analysis."
Possible regulations, Ruggio said, include unprecedented whistleblower protections and new fines and penalties for specific violations. All of these could have huge implications, he said.
"Remember, compounding pharmacies serve a big purpose," Ruggio said. "For those people who have allergies and sensitivities with regard to some mainline drugs, these companies can literally be a lifeline. Typically, these are not massive pharmaceutical companies. Excessive regulation could drive a lot of them out of business. Alternatively, it could drive the costs of their products too high, adding yet another burden to our already overburdened healthcare system."
Report forecasts surge in telehealth
NEW YORK — Telehealth is expected to reach 1.8 million patients around the world by 2017, according to a new report by healthcare market research firm IHS.
IHS’ InMedica division released the report, "The World Market for Telehealth – An Analysis of Demand Dynamics – 2012," projecting a sharp rise in the number of patients receiving telehealth. In 2012, there were about 308,000 patients remotely monitored by healthcare providers for congestive heart failure, chronic obstructive pulmonary disease, diabetes, hypertension and mental health conditions worldwide.
Telehealth, which will feature prominently at the Retail Clinician Education Congress in May, is also used to monitory ambulatory patients who have been diagnosed with a disease at an ambulatory care facility but have not been hospitalized. At the same time, telehealth has a much larger penetration in post-acute care compared with ambulatory care patients because the majority of patients are only considered for home monitoring following hospital discharge to prevent re-admission. In 2012, 140,000 post-acute patients were estimated to have been monitored by telehealth, compared with 80,000 ambulatory patients.
The majority of telehealth patients have congestive heart failure, while the number with COPD is projected to grow strongly as telehealth’s focus continues to expand to respiratory disease, the report found, but diabetes is expected to overtake COPD and account for the second-largest share of telehealth patients by 2017.
"A major challenge for telehealth is for it to reach the wider population of ambulatory care patients," InMedica analyst Theo Ahadome said. "However, the clinical and economic outcomes for telehealth are more established for post-acute care patients. Indeed, even for post-acute care patients, telehealth is usually prescribed only in the most severe cases, and where patients have been hospitalized more than once in a year."
The main drivers of demand are expected to be the federal government, as the Centers for Medicare and Medicaid Services looks to reduce readmission penalties; providers looking to use telehealth to increase ties to patients and improve care quality; payers looking to increase competitiveness; and patients, particularly those living in areas with poor availability of clinics and physicians.